(193 days)
The intended use of the Malibu system is as a temporary or permanent posterior, noncervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur.
The intended use of the Malibu spinal system, when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System, is to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The indications for use are as follows:
- . degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
- . severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion (indication for use only when used as a Spondylolisthesis Spinal Fixation Device System),
- spondylolisthesis. ●
- . trauma (i.e., fracture or dislocation),
- spinal stenosis.
- . deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
- . spinal tumor.
- . pseudoarthrosis, and/or
- failed previous fusion. .
The intended use and indications of the Malibu spinal system, when used as a Spinal Interlaminal Fixation Orthosis or Hook Spinal System, are limited to T1-L5 and are as follows:
- . degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
- spondylolisthesis .
- trauma (i.e., fracture or dislocation),
- . spinal stenosis.
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), ◆
- . tumor,
- pseudarthosis, and/or .
- . failed previous fusion.
The Malibu system will include cannulated polyaxial screws, closed lateral connectors, rod connectors, precontoured rods, and countoured crossbars. All products are fabricated from titanium alloy, with the exception of the screws which have a cobalt alloy component. All products are being offered in a wide variety of different sizes. The Malibu parts in this submission are being added to the current Malibu product line, but these items are also compatible with and work in conjunction with components in the UCR system. All product is supplied "NON-STERILE" and must be sterilized prior to use.
The Malibu Spinal System will also offer a wide variety of instruments that range from polyaxial screw drivers to bone probes. These instruments will be made from various grades of stainless steel with a few handles made from Radel and silicone. These items are supplied "NON-STERILE" and must be sterilized prior to use.
The provided document describes the Malibu™ Spinal System, which consists of various components for spinal fixation. This submission (K061342) is an addition to an existing product line. The device is a traditional medical implant, not an AI/ML powered device. Due to this, many of the requested criteria, such as "Multi Reader Multi Case (MRMC) comparative effectiveness study," "standalone (i.e. algorithm only without human-in-the-loop performance)," and "sample size for the training set," are not applicable.
Here's an analysis of the provided information, focusing on the available details:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Malibu Spinal System are based on substantial equivalence to predicate devices. This means that the device is considered safe and effective if it shares the same intended use, technological characteristics, and principles of operation as a legally marketed device, and does not raise new questions of safety or effectiveness.
The document reports that the device meets these criteria as shown in the "Comparison Analysis" table (Table 1).
| Feature | Acceptance Criteria (Substantial Equivalence to Predicate Devices) | Reported Device Performance (Malibu Spinal System) |
|---|---|---|
| Intended Use | Similar to predicate devices | Similar |
| Indications for Use | Similar to predicate devices | Similar |
| Design | Similar to predicate devices | Similar |
| Cannulated Polyaxial Screws | Similar to predicate devices (various sizes) | Similar (various sizes) |
| Closed Lateral Connectors | Similar to predicate devices (various sizes) | Similar (various sizes) |
| Rod Connectors | Similar to predicate devices (various sizes) | Similar (various sizes) |
| Precontoured Rods | Similar to predicate devices (various sizes) | Similar (various sizes) |
| Contoured Crossbars | Similar to predicate devices (various sizes) | Similar (various sizes) |
| Material | Similar to predicate devices (Titanium alloy, Cobalt alloy) | Similar (Titanium alloy, Cobalt alloy) |
| Sterile | Non-sterile, similar to predicate devices | Non-sterile |
| Method of Sterilization | High-temperature steam, similar to predicate devices | High-temperature steam |
| Mechanical Strength | All products passed testing per applicable standards. | All products passed testing per applicable standards. |
2. Sample Size Used for the Test Set and the Data Provenance
This is not applicable as the submission relates to a physical medical device (spinal fixation system) and not an AI/ML powered device or a study involving patient data. The "test set" in this context refers to mechanical testing according to established standards. The document states "All products passed testing per applicable standards," indicating that the devices were subjected to engineering integrity tests. Specific sample sizes for such mechanical tests are not detailed in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This is not applicable for a physical medical device. "Ground truth" for this type of device is established through engineering and material science standards, and the expertise would lie with engineers and metallurgists involved in the design, manufacturing, and testing of the components.
4. Adjudication Method for the Test Set
Not applicable in the context of an AI/ML powered device. For mechanical strength, compliance with standards usually involves predefined measurement criteria and acceptance limits, rather than a human adjudication process.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The Malibu Spinal System is a physical implant, not an AI/powered device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance would have been conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the Malibu Spinal System is based on engineering and material science standards, and performance benchmarks as established by predicate devices. The claim of substantial equivalence is based on the device's ability to meet the same mechanical strength, material composition, and functional design as previously cleared spinal fixation systems.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML system requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for a physical implant.
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.